Label: ADVANCED FLUORIDE ANTICAVITY- sodium monofluorophosphate paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 1, 2017

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  • Active IngredientDrug Facts

    Sodium Monofluorophosphate 0.76%

  • Purpose

    Anticavity toothpaste

  • Use

    Aids in the prevention of cavities

  • Warnings

    If more than is used for brushing is accidentally swallowed get medical help or contact a poison control center right away.

  • Keep out of reach of children

    Keep out of reach of children under 6 yrs of age.

  • Directions

    adults and children 2 years. and older: brush teeth thoroughly after meals or at least twice a day or as directed by a dentist.

    do not swallow

    to minimize swallowing, use a pea-sized amount in children under 6 years old

    supervise children's brushing until good habits are established

    children under 2y ears: ask a dentist before use.

  • inactive ingredients

    calcium carbonate, calcium hydrogen phosphate, carboxymethyl cellulose, flavor, glycerin, hydrated alumina, hydrated silica, potassium sorbate, saccharin sodium, sodium lauryl sulfate, sorbitan monooleate, sorbitol, titanium dioxide, water, xanthan gum.

  • ADVANCED FLUORIDE ANTICAVITY product label

    CAVITY FIGHTING TOOTHPASTE

    Distributed by:

    Personal Care Products, LLC

    Bingham Farms, MI 48025-2463

    Made in China

    Advanced Fluoride Anticavity Toothpaste

    New Ultra Breath Freshener Stripe

    Net Wt 6.4oz (181g)

    Multi
    Protection

    Fights Cavities

    Freshens Breath

    Advanced Anticavity Toothpaste

    Advanced Anticavity Toothpaste

    Advanced Anticavity Toothpaste

  • INGREDIENTS AND APPEARANCE
    ADVANCED FLUORIDE ANTICAVITY 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-9181
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1000 mg  in 181 g
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29500-9181-61 in 1 PACKAGE07/24/2017
    1181 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35507/24/2017
    Labeler - Personal Care Products, LLC (966155082)
    Registrant - Personal Care Products, LLC (966155082)
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